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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC HANDPIECE - STYLUS TOUCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
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MEDTRONIC XOMED INC. IPC HANDPIECE - STYLUS TOUCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE Back to Search Results
Model Number EM210RF
Medical Device Problem Codes Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found the motor seized and cannot perform pre-temperature test, the unit froze due to corroded motor and collet.Unit is physically damaged and is scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A health care professional (hcp) reported that the handpiece was making grinding noise and got very hot.There is no patient impact.
 
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Brand Name
IPC HANDPIECE - STYLUS TOUCH
Common Device Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key12348840
Report Number1045254-2021-00468
Device Sequence Number4633398
Product Code HBE
UDI-Device Identifier00643169945371
UDI-Public00643169945371
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K081475
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberEM210RF
Device Catalogue NumberEM210RF
Device Lot Number212938820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2021
Initial Report FDA Received Date08/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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